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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC MICROPITUITARY RONGEUR 9569565 INSTRUMENT, CUTTING, RONGEUR

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MEDTRONIC ADVANCED ENERGY, LLC MICROPITUITARY RONGEUR 9569565 INSTRUMENT, CUTTING, RONGEUR Back to Search Results
Model Number 9569565
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2017
Event Type  Injury  
Event Description
During a posterior spinal fusion, a micropituitary rongeur broke. It was not discovered that some pieces were missing from this instrument until it was put back on the tray. Some pieces recovered on back table. X-ray ordered. X-ray read as negative. Manufacturer: please note that we do not send products to the manufacturer, but you may arrange for pick-up by sending an e-mail to the address below.
 
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Brand NameMICROPITUITARY RONGEUR 9569565
Type of DeviceINSTRUMENT, CUTTING, RONGEUR
Manufacturer (Section D)
MEDTRONIC ADVANCED ENERGY, LLC
180 international drive
portsmouth NH 03801
MDR Report Key7288824
MDR Text Key100883184
Report NumberMW5075401
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9569565
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/21/2018 Patient Sequence Number: 1
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